NETWORKING IN REGULATORY CAPACITY BUILDING FOR VACCINES CATHERINE

NETWORKING IN REGULATORY CAPACITY BUILDING FOR VACCINES CATHERINE PARKER: HEALTH PRODUCTS AND FOOD BRANCH, HEALTH CANADA

NEW REGULATORY ERA • GROWING REALIZATION THAT NO SINGLE REGULATORY AUTHORITY HAS A MONOPOLY ON GOOD SCIENCE/APPROACHES NOR CAN ‘GO IT ALONE’ • CLOSER REGULATORY COOPERATION AND ‘NETWORKING’ A NATURAL RESPONSE TO THESE REALITIES • INTER-AGENCY AND COUNTRY LEVEL AGREEMENTS/ ARRANGEMENTS IN TURN SERVE AS KEY INSTRUMENTS THAT HELP GOVERN ENHANCED REGULATORY INTERACTIONS 2

INTERNATIONAL REGULATORY COOPERATION (IRC) • THE USE OF BILATERAL OR MULTILATERAL FORA TO DEVELOP BEST PRACTICE, SHARE KNOWLEDGE, ADOPT OR CONTRIBUTE TO INTERNATIONAL STANDARDS, OR DEVELOP COMPATIBLE APPROACHES WITH INTERNATIONAL COUNTERPARTS. • IT CAN INCLUDE: Ø Information sharing Ø Undertaking collaborative scientific work Ø Common data collection, risk assessment or compliance methods Ø Joint or parallel review Ø Developing common or international standards Ø Equivalency or Mutual Recognition Ø Harmonization 3

INTERNATIONAL REGULATORY COOPERATION APPROACH HEALTH PRODUCT AND FOOD BRANCH (HPFB) IRC APPROACH: 1. DEVELOP AND STRENGTHEN INTERNATIONAL RELATIONS WITH KEY REGULATORY COUNTERPARTS AND ORGANIZATIONS 2. ACTIVE COLLABORATION IN INTERNATIONAL STANDARDS SETTING AND HARMONIZATION INITIATIVES 3. STRATEGIC ENGAGEMENT WITH COUNTRIES WITH EMERGING REGULATORY SYSTEMS 4

1: PARTNERSHIP WITH KEY REGULATORY COUNTERPARTS AND ORGANIZATIONS • MOUS WITH KEY NRAS (E. G. US FDA, EMA) Ø Under the MOU, Health Canada has bilateral meetings/teleconferences with US FDA, EMA to further develop collaborative activities and to explore ways to work more effectively and more efficiently and to leverage resources (i. e. , expertise, funds, training, etc. ) through worksharing, such as strategic participation at multilateral fora. Ø Participate in EMA committees and/or working parties (e. g. Biosimilars Working Party, Vaccines Working Party and Biologics Working Party). • CONSORTIUM WITH HSA, SWISS MEDIC, TGA Ø Meetings of the heads of Medicines Regulatory agencies of Australia, Singapore and Switzerland take place on an annual basis and represent a unique opportunity for senior regulators from around the world to discuss regulatory challenges and develop collaborative solutions 5

2: COLLABORATION IN INTERNATIONAL STANDARDS SETTING AND HARMONIZATION INITIATIVES • WHO : Ø Expert Committee on Biological Standardization of WHO (ECBS) Ø WHO Blood Regulators Network (BRN) Ø WHO International Conference on Drug Regulatory Authorities (ICDRA) Ø WHOCC for Biological Standardization and Evaluation of Biologics • PAN-AMERICAN NETWORK FOR DRUG REGULATORY HARMONIZATION (PANDRH) Ø Biotech Working Group Ø Vaccines Working Group • LABORATORY COLLABORATIONS: Ø NIBSC (National Institute for Biological Standards and Control of the UK), in the field of blood product and vaccine testing methodology; Ø The European Directorate of Quality Medicines (EDQM); Ø The FDA’s Center for Biologics Evaluation and Research (CBER); Ø China's National Institute for the Control of Pharmaceutical and Biological Products ( NICPBP) /State Food and Drug Administration (SFDA). 6

3: STRATEGIC ENGAGEMENT WITH COUNTRIES WITH EMERGING REGULATORY SYSTEMS • HPFB HAS BEEN INVOLVED IN SEVERAL VACCINE REGULATORY CAPACITY BUILDING INITIATIVES INCLUDING: Ø Ø Vaccine and clinical trial regulation training (e. g. India); Participation in Pan American Network for Drug Regulatory Harmonization (PANDRH); Ø African Vaccines Regulatory Forum (AVAREF); Ø Developing Country Vaccine Regulators’ Network (DCVRN); and Ø Participating in Workshops on International Regulatory Capacity Enhancement for Influenza Vaccines (WHO and U. S. Department of Health, and Human Services (HHS) 7

VACCINE REGULATORY COOPERATION & NETWORKING CANADIAN HIV VACCINE INITIATIVE (CHVI) • JULY 2010, AT THE XVIII INTERNATIONAL AIDS CONFERENCE IN VIENNA, AUSTRIA, THE GOVERNMENT OF CANADA AND THE BILL & MELINDA GATES FOUNDATION RENEWED THEIR COMMITMENT OF UP TO $139 MILLION TO IMPLEMENT THE CANADIAN HIV VACCINE INITIATIVE. GOALS • • • TO ADVANCE THE BASIC SCIENCE OF HIV VACCINE DISCOVERY AND SOCIAL RESEARCH IN CANADA, AND LOW-AND-MIDDLE-INCOME COUNTRIES; TO SUPPORT THE TRANSLATION OF BASIC SCIENCE DISCOVERIES INTO CLINICAL TRIALS, WITH A FOCUS ON ACCELERATING CLINICAL TRIALS IN HUMANS; TO ADVANCE THE DEVELOPMENT OF RELATED TECHNOLOGIES; TO IMPROVE THE EFFICACY AND EFFECTIVENESS OF HIV PREVENTION OF MOTHER-TO -CHILD (PMTCT) SERVICES IN LOW-AND-MIDDLE-INCOME COUNTRIES BY DETERMINING INNOVATIVE IMPLEMENTATION STRATEGIES AND PROGRAMMATIC SOLUTIONS RELATED TO ENHANCING THE ACCESSIBILITY, QUALITY, AND UPTAKE OF HIV PMTCT SERVICES; AND TO ADDRESS THE ENABLING CONDITIONS TO FACILITATE REGULATORY APPROVAL AND COMMUNITY PREPAREDNESS. 8

VACCINE REGULATORY COOPERATION & NETWORKING CANADIAN HIV VACCINE INITIATIVE (CHVI) • CHVI FUNDING HAS ALLOWED HPFB TO PLAY A GREATER ROLE IN ADDRESSING REGULATORY CAPACITY NEEDS IDENTIFIED BY NRAS. • SOME ACTIVITIES INCLUDE: Ø Ø Ø HPFB International Regulatory Forum; African Vaccines Regulatory Forum (AVAREF); Training/Information sessions for NRAs provided through participation at vaccine and clinical trial forums and conferences, such as the WHO Pre-qualification Process Workshops (Kenya and Burkina Faso), Satellite Symposiums at AIDS Vaccine Conferences; CHVI Mentorship Program with the countries of Malawi and Nigeria; and Development of a road-map for HIV vaccine researchers outlining the vaccine development process in Canada and internationally. 9

CONCLUSION ENABLERS TO EFFECTIVE COOPERATION: • POLITICAL AND INSTITUTIONAL COMMITMENT • COMMON APPROACHES (E. G. GUIDANCE DOCUMENTS) • TRANSPARENCY AND TRUST (E. G. BILATERAL AND TRILATERAL TELECONS. ) • INVESTMENT OF RESOURCES (E. G. HPFB INTERNATIONAL REGULATORY FORUM) • MECHANICS: ARRANGEMENTS (MOUS), VIRTUAL NETWORKS AND SECURE INFORMATION PLATFORMS • PRACTICAL, RELEVANT AND FLEXIBLE APPROACHES THAT RESULT IN TANGIBLE BENEFITS (E. G. PARALLEL REVIEW WITH INDIAN NRA) • COOPERATION AT REGIONAL AND INTERNATIONAL LEVELS 10

CONCLUSION TRENDS AND PRIORITIES • GROWING NUMBER OF REGULATORY NETWORKS • EXPANSION AND LINKAGES BETWEEN HARMONIZATION INITIATIVES (HARMONIZING APPROACHES, NOT HARMONIZING REGULATIONS) • POOLING OF RESOURCES/CAPACITY: Ø Ø Work-sharing Mutual/unilateral recognition (help to make decisions while respecting context-specific risk management approach) • INCREASING FOCUS ON MULTILATERAL INITIATIVES • INSPECTION AND POST-MARKET SURVEILLANCE ACTIVITIES. 11

THANK YOU! GRACIAS! MERCI! CATHERINE PARKER BIOLOGICS AND GENETIC THERAPIES DIRECTORATE HEALTH PRODUCTS AND FOOD BRANCH, HEALTH CANADA EMAIL: CATHY. [email protected] GC. CA TELEPHONE: (001)613 -946 -0099 12